Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | REGENT MECHANICAL HEART VALVE, STANDARD MECHANICAL HEART VALVE, MASTER MECHANICAL HEART VALVE |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | Abbott Medical 177 County Road B. East St. Paul, MN 55117 |
PMA Number | P810002 |
Supplement Number | S085 |
Date Received | 04/30/2013 |
Decision Date | 05/30/2013 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE TO THE CLEAN ROOM FOR THE SJM MECHANICAL HEART VALVES, AND A CHANGE IN THE VAVGJ PACKAGE SEALING PARAMETERS. |
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